Full Throttle at invivodata

Pittsburgh's invivodata is on a roll. The 90-employee company recently raised $10 million, one third of it in a line of credit, and two-thirds from River Cities Capital Funds, a venture capital.

Invivodata is also partnering with one of the top electronic data capture (EDC) firms, Medidata. way of proof, invivodata and Medidata offered up Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical, and regulatory affairs at Nabi Biopharmaceuticals. Nabi is already taking advantage of the invivodata-Medidata alliance.

Nabi, for the record, is working on a way to use the immune system to assist in smoking cessation. With nine clinical sites, the company's goal is to enlist 300 patients in a Phase IIb trial by the end of 2006. A Phase III study could start by the middle of 2007.

Rasmussen formerly worked at Pfizer, among other places, and had wanted to do an EDC trial at Nabi. But that small company didn't want to jump in rashly. "We wanted to make sure the timing was right," he says of EDC. "We wanted to make sure we chose the right technology."

Nabi designed a trial with a daily check-in with a handheld device from invivodata. "The patients are taking diaries home and recording their smoking on a real time basis," says Rasmussen. "It works very well for us. It allows for very rapid data collection and analysis."

Bob Young, senior vice president of sales and marketing at invivodata, says, "integrating our proven eDiary technology with Medidata's user-friendly Rave electronic data capture (EDC), management and reporting system, we are enabling Nabi to conduct more efficient research and advance its development of safe and effective medical treatments."

The founder, president and CEO of invivodata, Doug Engfer, says the new capital infusion will allow his company to breathe easier. "It really positions us to get the resources we need to not only respond to the market growth, but anticipate where customers are going," he says. "We're here for the long haul and committed to the space."

Engfer says the company expects to grow even more rapidly in the year ahead. "We had the highest level of interest in the company we've ever seen. We've been growing on average 60 percent a year. We see that being much faster this year."

Part of support for such expansion, he suggests, is due to the fact that the significance of the FDA's past and future guidances on the topic is sinking in within the industry at large. As Engfer puts it: "There is a solid dialogue and conversation going on out there that is very constructive. It should continue to support the adoption of approaches that improve the integrity of the data."

There is a consensus on that at the other part of the partnership serving Nabi. "The quality of data that Nabi is going to have is going to be higher," notes Glen de Vries, Medidata's cofounder and chief technical officer. "Nabi had a lot of foresight in seeing the value of combining their electronic patient-reported outcome data with EDC on an ongoing basis."

De Vries insists that there are not two types of data that have to be painfully merged at some point. Yes, he says, others in the industry may do it that way. "They think of the end game first. 'We have two data sets that had to be combined into one.' Whereas in both [Medidata EDC application] Rave and invivodata, there is a metadata model that describes how data is stored and managed."

Just sharing data is easy, de Vries says. "But one of the things that can create a lot of headache are all the business rules around that data, how you handle a conflicting record. That is where a lot of pain comes in. We can provide customers a way to dictate how both systems handle the data that appears de novo in both systems. We've already done the thinking about how the diary data should appear in RAVE and gotten all the business rule considerations taken care of in advance. We're not saying integrations are easy. We're saying it's possible to come to the table with a lot of the hard parts of an integration thought about and taken care of already," he says.